KVUS at Neoadjuvant CTx of Breast Cancer
Primary Purpose
Early Primary Breast Cancer
Status
Unknown status
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
SonoVue
Sponsored by
About this trial
This is an interventional treatment trial for Early Primary Breast Cancer focused on measuring breast cancer, neoadjuvant chemotherapy, ultrasound, microbubbles
Eligibility Criteria
Inclusion Criteria:
- written informed consent
- age > 18 yrs
- histologically confirmed primary breast cancer including all intrinsic subtypes
- treatment with neoadjuvant chemotherapy
- persons who are legally competent and mentally able to follow the instructions of the study team
Exclusion Criteria:
- hypersensitivity / allergy to sulfur hexafluoride, Macrogol 4000, distearoylphosphatidylcholine, dipalmitoylphosphatidylglycerol-sodium, palmitic acid
- right-left shunt,
- severe pulmonary hypertension (pulmonary arterial pressure > 90 mmHg)
- uncontrolled systemic hypertension
- acute respiratory distress syndrome
- pregnancy
- commitment of the patient to any resident institution by order of any court or authority
- expectation of missing compliance
- alcohol or drug abuse
- patients who are in a relationship of dependence or in a working relationship to the sponsor, the investigator or his representative
Sites / Locations
- Department of Gynecology and ObstetricsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
A
B
Arm Description
Application and measurement of tumor size using contrast agent-enhanced diagnostic and therapy supporting (with SonoVue®) ultrasound
Application and measurement of tumor size using contrast agent-enhanced diagnostic ultrasound
Outcomes
Primary Outcome Measures
Tumor size reduction (1)
pCR (pathohistological complete remission)
Tumor size reduction (2)
cCR (clinical complete remission)
Tumor size reduction (3)
measured by ultrasound (% reduction in therapy)
Secondary Outcome Measures
proliferation rate of the tumor cells
Ki67 protein analysis
narrowing the invasion front of the tumors
ultrasound
macrophage density in the tumor
serum chemistry
vascularization of the tumor
ultrasound
tolerability of chemotherapy
% reduction in therapy
Full Information
NCT ID
NCT03385200
First Posted
December 19, 2017
Last Updated
December 27, 2017
Sponsor
RWTH Aachen University
Collaborators
Univ.-Prof. Dr. med. F. Kiessling
1. Study Identification
Unique Protocol Identification Number
NCT03385200
Brief Title
KVUS at Neoadjuvant CTx of Breast Cancer
Official Title
Contrast-enhanced Ultrasound in Neoadjuvant Chemotherapy of Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 12, 2016 (Actual)
Primary Completion Date
June 12, 2019 (Anticipated)
Study Completion Date
December 12, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
RWTH Aachen University
Collaborators
Univ.-Prof. Dr. med. F. Kiessling
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Effect of the contrast-enhanced diagnostic ultrasound during neoadjuvant chemotherapy of breast cancer on the achieved tumor size reduction and tolerability of chemotherapy
Detailed Description
The 5-year survival rate of breast cancer patients is decreasing in the advanced, metastatic stage from 99% to 26%. Therefore an optimization of the therapy of advanced breast cancer is urgently needed.
To increase the echogenicity of the blood in the ultrasound, microbubbles were developed working as stable, biocompatible contrast agent in ultrasound. Such a clinically approved ultrasound contrast agent is SonoVue® (Bracco International B.V., Amsterdam). SonoVue® is approved by the European Medicines Agency (EMA) (approval number EU/1/01/177/002) for the visualization of focal vascularization lesions of the liver and breast within Doppler sonography and is applied in breast cancer patients primarily for the purpose of diagnosis as well as to evaluate the response to the neoadjuvant used chemotherapy.
Animal studies using the contrast enhanced ultrasound have shown that the administration of this contrast agent increases the penetration and accumulation of drugs in the tumor as well as the permeability of the blood-brain barrier resulting in a precise and effective drug distribution. In the tumor animal model it could be shown that a combined treatment with chemotherapy and contrast enhanced ultrasound results in a decreased tumor growth and a prolonged survival. Patients with inoperable pancreatic cancer showed a reduced tumor growth and better tolerability of chemotherapy when administrating the contrast enhanced diagnostic ultrasound during palliative chemotherapy. This could be due to the better tumor response, but also due to the more targeted chemotherapy distribution.
The purpose of this study is to examine whether the use of the contrast enhanced diagnostic ultrasound during neoadjuvant chemotherapy results in an increased tumor regression in comparison to native ultrasound. It is an Investigator Initiated Trial and is funded by internal means.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early Primary Breast Cancer
Keywords
breast cancer, neoadjuvant chemotherapy, ultrasound, microbubbles
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Parellel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Active Comparator
Arm Description
Application and measurement of tumor size using contrast agent-enhanced diagnostic and therapy supporting (with SonoVue®) ultrasound
Arm Title
B
Arm Type
No Intervention
Arm Description
Application and measurement of tumor size using contrast agent-enhanced diagnostic ultrasound
Intervention Type
Drug
Intervention Name(s)
SonoVue
Intervention Description
As part of the study therapy supportive ultrasound will be performed with iv Infusion of the chemotherapeutic agent.
Primary Outcome Measure Information:
Title
Tumor size reduction (1)
Description
pCR (pathohistological complete remission)
Time Frame
18 / 24 weeks
Title
Tumor size reduction (2)
Description
cCR (clinical complete remission)
Time Frame
18 / 24 weeks
Title
Tumor size reduction (3)
Description
measured by ultrasound (% reduction in therapy)
Time Frame
18 / 24 weeks
Secondary Outcome Measure Information:
Title
proliferation rate of the tumor cells
Description
Ki67 protein analysis
Time Frame
18 / 24 weeks
Title
narrowing the invasion front of the tumors
Description
ultrasound
Time Frame
18 / 24 weeks
Title
macrophage density in the tumor
Description
serum chemistry
Time Frame
18 / 24 weeks
Title
vascularization of the tumor
Description
ultrasound
Time Frame
18 / 24 weeks
Title
tolerability of chemotherapy
Description
% reduction in therapy
Time Frame
18 / 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
written informed consent
age > 18 yrs
histologically confirmed primary breast cancer including all intrinsic subtypes
treatment with neoadjuvant chemotherapy
persons who are legally competent and mentally able to follow the instructions of the study team
Exclusion Criteria:
hypersensitivity / allergy to sulfur hexafluoride, Macrogol 4000, distearoylphosphatidylcholine, dipalmitoylphosphatidylglycerol-sodium, palmitic acid
right-left shunt,
severe pulmonary hypertension (pulmonary arterial pressure > 90 mmHg)
uncontrolled systemic hypertension
acute respiratory distress syndrome
pregnancy
commitment of the patient to any resident institution by order of any court or authority
expectation of missing compliance
alcohol or drug abuse
patients who are in a relationship of dependence or in a working relationship to the sponsor, the investigator or his representative
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elmar Stickeler, Univ.-Prof. Dr. med.
Phone
+49 241 80 88400
Email
estickeler@ukaachen.de
First Name & Middle Initial & Last Name or Official Title & Degree
Fabian Kiessling, Univ.-Prof. Dr. med.
Phone
+49 241 80 80116
Email
fkiessling@ukaachen.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elmar Stickeler, niv.-Prof. Dr. med.
Organizational Affiliation
Department of Gynecology and Obstetrics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Gynecology and Obstetrics
City
Aachen
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elmar Stickeler, Univ.-Prof. Dr. med.
Phone
+49 241 80 88400
Email
estickeler@ukaachen.de
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
The study results will be published in at least one scientific article.
Learn more about this trial
KVUS at Neoadjuvant CTx of Breast Cancer
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